The Medical Devices Clinical Team for EMEA based in Brussels is looking for a Site-Clinical Study Coordinator (Site-CSC).
The Site-Clinical Study Coordinator (Site-CSC) provides administrative support to the study team throughout the study. This is achieved by ensuring timely filing of study documents, creation, and shipment of patient and regulatory binders as well as study materials. The Site-CSC works closely with the Site-inhouse CRA (Site-ICRA) within Site Operations. By providing this administrative support, the Site-CSC contributes to ensuring site audit readiness.

Roles & Responsibilities:

• Create the table of content for the Study Site Regulatory Binder Template in collaboration and under the supervision of study management.
• Prepare the Study Site Regulatory Binder and Patient Binder with all study-approved documents.
• Perform quality checks on Site-specific Regulatory and Patient binders.
• Pack and send binders to colleagues and/or study sites.
• Quality check and file site and sponsor correspondence, EC submission packages, and document uploads in the Trial Master File.
• Contribute to and assist with site audit readiness.
• Track submission and correspondence on essential study site documents.
• Act as point of contact within the Site-CSC team for the assigned Business Unit.
• Attend study-related meetings.
• Maintain records of investigational devices for all assigned regulated studies, if applicable in the region.
• Assist with sending study communication such as newsletters and mailings to sites.
• Support and track shipment of project-related equipment/data between sites, sponsor, and core labs.

Your Profile:

• High school diploma/secondary school degree.
• One-year clinical research experience or related device/pharmaceutical experience or relevant clinical experience in a clinical/hospital environment.
• Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
• Strong organizational skills and attentiveness to detail.
• Verbal and written communication, interpersonal, and basic math skills.
• Ability to read, write, and communicate effectively in English, including clear, understandable speech, comprehension skills, and competence in English spelling, grammar, and punctuation.
• Ability to use discretion and handle sensitive/confidential information.
• Ability to work independently when necessary.
• Ability to exchange straightforward information, ask questions, and check for understanding.
• Must be able to maintain regular and predictable attendance.

Our Offer:

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and development.
• A collaborative and innovative work environment.
• Comprehensive health and wellness programs.
• Employee assistance programs and work-life balance initiatives.
• Access to continuous learning and development opportunities.
• Supportive and inclusive company culture.

• Create the table of content for the Study Site Regulatory Binder Template in collaboration and under the supervision of study management.
• Prepare the Study Site Regulatory Binder and Patient Binder with all study-approved documents.
• Perform quality checks on Site-specific Regulatory and Patient binders.
• Pack and send binders to colleagues and/or study sites.
• Quality check and file site and sponsor correspondence, EC submission packages, and document uploads in the Trial Master File.
• Contribute to and assist with site audit readiness.
• Track submission and correspondence on essential study site documents.
• Act as point of contact within the Site-CSC team for the assigned Business Unit.
• Attend study-related meetings.
• Maintain records of investigational devices for all assigned regulated studies, if applicable in the region.
• Assist with sending study communication such as newsletters and mailings to sites.
• Support and track shipment of project-related equipment/data between sites, sponsor, and core labs